BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3836540 · Received May 28, 2014

    Report

    Report Number
    2953200-2014-01067
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6-7 CM DIAMETER ABDOMINAL AORTIC ANEURYSM AND 7 CM RIGHT COMMON ILIAC ARTERY ANEURYSM. THE PATIENT WAS SYMPTOMATIC (NATURE OF THE SYMPTOMS ARE UNKNOWN); HOWEVER, DID NOT HAVE A RUPTURE. IT WAS REPORTED THAT THERE DIFFICULTY CANNULATING THE CONTRALATERAL GATE. ANOTHER PHYSICIAN WAS CALLED IN AND SUCCESSFULLY CANNULATED THE GATE AND IMPLANTED A 1624124 CONTRALATERAL LIMB. THE PHYSICIAN ELECTED TO COIL WHAT WAS THOUGHT TO BE THE RIGHT HYPOGASTRIC ARTERY; HOWEVER, THE COILS WERE PLACED IN THE 7 CM RIGHT COMMON ILIAC ARTERY ANEURYSM. A 161682 AND 161093 WERE IMPLANTED ON THE RIGHT SIDE; HOWEVER, THERE WAS A TYPE IB ENDOLEAK WHICH REQUIRED A 162082 TO BE IMPLANTED. AT THIS POINT THE TABLE MOVED AND THE STENT GRAFT WAS INACCURATELY DEPLOYED IN THE FEMORAL ARTERY WHICH WAS 8 MM IN DIAMETER BUT THE ENDOLEAK WAS RESOLVED. A 242482 LEFT CONTRALATERAL EXTENSION WAS IMPLANTED ON THE LEFT SIDE AND THERE APPEARED TO BE A SEAL, BUT THE ANGIO SHOWED A CONTINUED ENDOLEAK IN THE SAC, THEREFORE, A 2514102 ENDURANT AUI WAS IMPLANTED ON THE LEFT IN ORDER TO PRESERVE THE LEFT HYPOGASTRIC ARTERY. A 24 MM TALENT OCCLUDER THAT WAS PLACED ON THE RIGHT SIDE FOLLOWED BY A FEM-FEM BYPASS. THERE WAS STILL A TYPE IB ENDOLEAK ON THE RIGHT, BUT ITS EXACT LOCATION COULD NOT BE DETERMINED. POST ANGIO WAS DONE AND INDICATED A TYPE 1A AND TYPE 1B ENDOLEAK. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND AN INITIAL ANGIO INDICATED A TYPE 3 JUNCTION ENDOLEAK. THE PHYSICIAN DECIDED TO PLACE A 1616124 TO SEAL THE ENDOLEAK. THE ENDOLEAK DID NOT RESOLVE AND ANOTHER MANUFACTURER¿S STENT WAS MOUNTED ON A BALLOON AND INFLATED AND PLACED IN THE LEFT LIMB. THE ENDOLEAK WAS REDUCED. THE PHYSICIAN SUCCESSFULLY COILED THE RIGHT HYPO THEN PLACED AMPLATZER PLUGS AND COILS IN THE RIGHT OCCLUDED LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER WITH AN OCCLUSION OF THE STENT GRAFTS. THE PHYSICIAN THOUGHT THE OCCLUSION STEMMED FROM A KINK IN THE RIGHT LIMB DUE TO AN UNKNOWN CAUSE, WHICH PROPAGATED THE OCCLUSION INTO THE MAIN BODY AREA. THE PHYSICIAN STATED THE PATIENT WAS BEING TRANSFERRED TO ANOTHER FACILITY UNDER THE CARE OF A DIFFERENT PHYSICIAN WHERE AN AX BY FEM BYPASS WAS DONE TO RESTORE BLOOD FLOW TO THE PATIENTS LEGS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312975 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04041165

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention